US8945227B2 - Spinal implant co-insertion system and method - Google Patents

Abstract

A system and method for substantially simultaneous co-insertion of an implant, such as a cage and plate. An inserter is secured to the cage and plate and is used to hold the components while implanting the components during a surgical procedure.

Description

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims priority to provisional U.S. application Ser. No. 61/300,102 filed Feb. 1, 2010, to which Applicant claims the benefit of the earlier filing date. This application is incorporated herein by reference and made a part hereof.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to spinal implants and, more particularly, to a co-insertion system and method for substantially simultaneously inserting or implanting a cage and plate in a patient during a surgical procedure.

2. Description of the Related Art

In order to stabilize two adjacent vertebrae of the spine, surgeons will typically place two components. The first is a bone-filled generally cuboidal device, termed a cage, in-between the adjacent vertebrae. The second is a plate device bridging the adjacent vertebrae and attached to the vertebrae via bone screws or similar means. The placement of these two devices is performed in a serial fashion with additive operative time. Additionally, different insertion instruments are utilized for the plate and cage components, resulting in increased cost, complexity and duplication.

Recently, there have been efforts to integrate the plate and cage components into either a unified or mechanically coupled device as exemplified by U.S. Pat. No. 6,235,059, which is incorporated herein by reference and made a part hereof. An advantage of such a unified device is that it creates efficiency for the surgeon by reducing the number of implantation steps and instruments. A disadvantage of such a device is that it doesn't allow for uncoupled motion between the cage and plate components, despite the fact that these components are subjected to differing biomechanical loads after implantation.

What is needed, therefore, is a combination cage-plate device with a co-inserter instrument that allows for loading of both implants on a single inserter and simultaneous co-implantation of separate plate and cage components. The inserter can be removed following implantation resulting in the appropriate positioning of the two independent and uncoupled components.

SUMMARY OF THE INVENTION

One object of the invention is to provide a combination cage-plate device with a co-inserter that allows for substantially simultaneous loading and placement of both the cage and plate on the co-inserter.

Another object of the invention is to provide a system and method for simultaneous co-implantation of the separate plate and cage components of an implant.

Still another object of the invention is to provide an inserter for inserting a cage and plate that can be removed following implementation of the two independent and un-coupled components.

In one aspect, one embodiment of the invention comprises a spinal implant co-insertion system comprising an inserter having a handle and an inserter fastener, a cage having at least one coupler adapted to be fastened to the inserter fastener a plate, the inserter being adapted to simultaneously receive the plate and the cage for simultaneous co-implantation of the plate and cage.

In another aspect, another embodiment of the invention comprises a plate for use in a spinal implant co-insertion system, comprising a body, the body having an internal wall that defines a through-hole for receiving an inserter having an inserter end that is screwed into a cage so that the inserter can simultaneously receive the cage and the plate so that they can be simultaneously implanted during a surgical procedure.

In still another aspect, another embodiment of the invention comprises a method for co-inserting a cage and a plate during a surgical procedure, the method comprising the steps of coupling an inserter to the cage and the plate so that the inserter simultaneously receives and supports the cage and plate, simultaneously implanting the cage and plate using the inserter during a surgical procedure, removing the inserter from the cage and removing the inserter from the plate.

These and other objects and advantages of the invention will be apparent from the following description, the accompanying drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view illustrating a system for co-insertion of an implant having a cage and plate during a surgical procedure in accordance with one embodiment of the invention;

FIG. 2 is a perspective view showing the system ofFIG. 1;

FIG. 3 is an exploded view showing the cage, plate and inserter shown in assembled form inFIGS. 1 and 2;

FIG. 4 is a view showing various details of the plate;

FIG. 5 is another exploded view showing the plate with a threaded aperture for threadably receiving the inserter;

FIGS. 6A and 6B are views of an embodiment showing the inserter traversing a substantial depth of the cage and fastener to a rear wall; and

FIGS. 7A-7C are various fragmentary views illustrating different exemplary embodiments for fastening or coupling the inserter to the cage.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now toFIG. 1, a system andmethod10 for substantially simultaneous co-insertion of acage12 andplate14 with aninserter16 are shown. Thesystem10 includes theinserter16 which comprises a grip orfirst end16aand asecond end16bthat is threaded as described later herein.

Theinserter16 further comprises an integralelongated portion16cwhich couples thefirst end16ato thesecond end16b.

Theinserter16 comprises a stop orshoulder18. As described in more detail later herein, the shoulder18 (FIG. 3) engages theplate14 as described later herein.

In the illustration being described and as mentioned, thesecond end16bcomprises aninserter fastener20 which in the illustration being described comprisesthreads22. Although theinserter fastener20 is shown as havingthreads22 in the illustration, it should be understood that theinserter fastener20 could be any suitable means for coupling theinserter16 to at least one of thecage12 orplate14 so that they may be substantially simultaneously mounted on theinserter16 and implanted into a patient P (FIG. 1) during a surgical procedure. It should be understood that while the illustration described shows a threaded coupling between thecage12 and inserter16, a non-threaded fastener, coupler or coupling means may be used. For example,FIG. 7A shows a camming coupling21aat theend16bwith a complementary coupling aperture21bin thecage12.FIG. 7B shows a keying connection23awith a complementary keying coupling aperture23b.FIG. 7C shows a spreading orclamping coupling25aatend16band a complementary spreading or clampingaperture25b.

For ease of illustration,FIG. 1 shows theinserter16 being used to substantially simultaneously insert thecage12 andplate14 into the patient such that thecage12 becomes situated between afirst vertebra24 and asecond vertebra26 as illustrated. In the illustration being described, at least one or a plurality ofscrews28 may be received in at least oneaperture40 and42 of theplate14 and screwed into, for example, thefirst vertebra24 in a manner conventionally known in order to secure theplate14 thereto. In the illustration, theplate14 is not secured, coupled or fixed to thecage12 and can move, migrate or float with respect thereto. Thecage12 andplate14 are separate components.

Referring now toFIGS. 2 and 4, note that thecage12 comprises a plurality ofapertures30 through which a graft material15 (FIG. 1) may be inserted or packed into thecage12. Thecage12 further comprises at least onecoupler32. In the illustration being described, the at least onecoupler32 has a threadedcage wall32athat defines a threadedopening34 for receiving thethreads22 of theinserter16 as illustrated inFIGS. 1-3. The at least onecoupler32 andinserter fastener20 may be any suitable means or method for affixing a portion, such as thesecond end16b, of theinserter16 to thecage12 after theinserter16 has received theplate14. While the illustration being described illustrates that theinserter fastener20 is at thesecond end16bof theinserter16, it should be understood that it does not necessarily have to be on thesecond end16b, and it could be situated at other locations on theinserter16.

Referring back toFIG. 3, note that thecage12 further comprises at least one or a plurality of aligningwalls36 that define at least one or a plurality of aligningapertures38 as shown. The function and operation of the at least one or a plurality of aligningapertures38 will be described later herein.

Referring now toFIG. 3, note that theplate14 comprises a first side14aand asecond side14bas shown. Theplate14 is adapted or configured to define a plurality ofscrew receiving openings40 and42 which have an associatedintegral lock44 and46, respectively. The operation of the integral lock is similar to that described in U.S. Pat. Nos. 7,182,782; 7,641,701; 7,655,028 and U.S. Patent Publications 2006/0195100; 2007/0123885; 2008/0021476 and 2010/0145453, all of which are incorporated herein by reference and made a part hereof. Features of the plates in those references may also be used in the embodiments being described.

Theplate14 has aninternal wall48 that defines a through-hole50 for receiving thesecond end16bof theinserter16. In the illustration shown inFIG. 3, the through-hole50 is not threaded and is sized to permit thethreads22 ofinserter16 to pass through the through-hole50. In this regard, thesecond end16bof theinserter16 has a shank or elongated portion25, a portion of which comprises thethreads22 and an unthreadedportion23 as illustrated inFIG. 3. In the illustration being shown inFIG. 2, theinternal wall48 becomes operatively associated with the unthreadedportion23 after thesecond end16bis inserted in the through-hole50 as shown.

As shown inFIGS. 3 and 5, theplate14 may further comprise a receivingshoulder52 for receiving the stop orshoulder18 so that theplate14 does not ride along an unthreaded shank portion or end16dof theinserter16.

As illustrated inFIGS. 3 and 5, thesecond end16bis inserted through the through-hole50 of theplate14 and then screwed into the threadedopening34 so that theplate14 becomes secured between the stop orshoulder18 and thecage12 as shown. Once thecage12,plate14 andinserter16 are secured together, theinserter16 may be used to position thecage12 between thefirst vertebra24 and thesecond vertebra26 and held in place while at least onescrew28 is received in the at least oneaperture40 and42 and screwed into bone. After theplate14 andcage12 are operatively positioned and secured to the bone, theinserter16 is unscrewed from thecage12 and withdrawn from theplate14 and the patient.

In one embodiment and in order to maintain the relationship of thecage12 to theplate14 during insertion, at least one of or both of thecage12 orplate14 may comprise at least one or plurality ofaligners54 and56 (FIG. 4). The at least one or plurality ofaligners54 and56 are integrally formed in theplate14 as shown. The at least one or plurality ofaligners54 and56 are received in the aligningapertures38 and cause theplate14 to be generally aligned with thecage12 after theinserter16 receives theplate14 andcage12. Of course, other means for aligning theplate14 relative to thecage12 may be provided.

The at least one or plurality ofaligners54 and56 facilitate aligning thecage12 to theplate14 and also facilitate preventing theplate14 orcage12 from any rotational movement when theinserter16 is unscrewed or dismounted from thecage12 andplate14. In the illustration being described, the at least one or plurality ofaligners54 and56 are integral projections that extend away fromsurface14bas shown inFIGS. 4 and 5.

FIG. 5 illustrates another embodiment wherein theplate14 comprises an internal threadedwall60 as shown. In this embodiment, thesecond end16bof theinserter16 hasthreads22 that are long enough to screw into both theplate14 and thecage12 to threadably secure thecage12 andplate14 together.

Although the embodiments being shown and described herein illustrate various means for securing thecage12 andplate14 together using thethreads22 that are threadably received in at least one or both of thecage12 andplate14, other means for securing theinserter16 to thecage12 andplate14 may be used without departing from the true spirit and scope of the invention.

The system andmethod10 for co-inserting thecage12 andplate14 into the patient during a surgical procedure will now be described. In general, theend16dof theinserter16 is passed through the through-hole50 and then screwed into the threadedopening34 in thecage12. Note that if the embodiment ofFIG. 5 is used, then the threadedsecond end16bof theinserter16 is screwed first into theinternal wall48 of theplate14 and then into the threadedopening34 of thecage12 to secure thecage12 andplate14 to theinserter16. In either embodiment, the stop orshoulder18 is received in the receivingshoulder52 of theplate14.

Theinserter16 substantially simultaneously receives and supports thecage12 andplate14 so that simultaneous implanting of thecage12 andplate14 using theinserter16 can be performed during a surgical procedure. In this regard, note inFIG. 1 that theco-insertion system10 enables thecage12 and theplate14 to substantially simultaneously be positioned such that thecage12 is received in the area between thevertebra24 andvertebra26.

After thecage12 andplate14 are positioned, theinserter16 may be unscrewed or rotated and removed from thecage12 andplate14. In this regard, note that theinserter16 may be held in place while at least one of the plurality ofscrews28 is used to secure theplate14 to at least one of thevertebra24 or26. Thereafter, theinserter16 may be unscrewed from thecage12 and/orplate14. It should be understood, therefore, that theinserter16 is first removed from thecage12 and then removed from theplate14 at the end of the surgical procedure. In contrast theinserter16 is inserted first through theplate14 and then into thecage12 when theinserter16 is mounted to these components.

As alluded to earlier herein, when theinserter16 is mounted to thecage12 andplate14, the at least one or plurality ofaligners54 and56, may be used to align and maintain alignment of thecage12 andplate14 together.

Advantageously, the system andmethod10 enable the co-insertion or substantially simultaneous insertion of thecage12 andplate14 using a single tool, namely, theinserter16. In a preferred embodiment, thecage12 is first packed or loaded with the graft material15 (FIG. 1) either before or after theplate14 andcage12 are mounted on theinserter16. Alternatively, thegraft material15 may be inserted or packed into thecage12 after it is positioned in the patient.

Other features may include:

1. At least one or a plurality of bone-penetrating prongs (not shown) may be situated on thesecond side14bof theplate14 to penetrate the bone and facilitate stabilizing theplate14 during or following insertion or when theinserter16 is removed from theplate14 andcage12.

2. Note that the at least one or plurality ofaligners54 and56 are illustrated as being integral with theplate14, other types of aligners could be used and/or the aligners could be situated on or even integral with thecage12, with theplate14 being adapted to receive the at least one or plurality ofaligners54 and56, such as by providing receiving apertures in theplate14.

3. Another feature of the system andmethod10 described herein is that it facilitates or enables implantation of two independent and un-coupled components, namely thecage12 andplate14. In this regard, even if the components comprise an aligner, thecage12 andplate14 are not coupled directly together in the illustrations being described. It is envisioned that this feature of theplate14 relative to thecage12 can be provided similar to that which is shown in U.S. Pat. No. 7,182,782, which is owned by the Assignee of the present application and which is incorporated herein by reference and made a part hereof.

4. Theplate14 may be comprised of a shortenedlength plate14 which does not extend past the upper and lower borders of thecage12.

5. Theplate14 may incorporate various screw-plate locking mechanisms to prevent rotation and/or expulsion of fixation screws28.

6. Theplate14 may comprise various screw arrangements and/or angulations, such as oneupward screw28 or downward screw alone; one upward and one downward; two upward and one downward; one upward and two downward; or two upward and two downward or the like.

7. Thecage12 may comprise a reduced, fenestrated or eliminated front wall, such that theinserter16 can transverse theplate14 and a substantial depth of thecage12 with theinserter16 engaging a rearward wall12aof thecage12. This feature is illustrated inFIGS. 6A and 6B and shows theinserter16 traversing the depth of thecage12 so that it can fasten to a rear wall12aof thecage12 as shown.

8. Theinserter16 tocage12 mechanical coupling may incorporate various fixation means mentioned earlier, such as threading, camming, keying, spreading, clamping and otherwise reversibly locking theinserter16 to thecage12.

In the illustrations, the components can be made from any biocompatible material. Potential biocompatible materials comprise metals (for example, titanium), metal alloys (for example, titanium alloy), carbon fibers, composites, polymers or hybrid materials.

While the system and method herein described constitute preferred embodiments of this invention, it is to be understood that the invention is not limited to this precise system and method, and that changes may be made therein without departing from the scope of the invention which is defined in the appended claims.

Claims (21)

What is claimed is:

1. A spinal implant co-insertion system comprising:

an inserter having a handle and an inserter fastener;

a cage having at least one coupler adapted to be fastened to said inserter fastener; and

a plate;

said inserter being adapted to simultaneously receive said plate and said cage for simultaneous co-implantation of said plate and cage;

wherein said inserter fastener comprises at least one of threads, a cam, a key, a spread or a clamp, said at least one coupler of said cage being adapted to be fastened or coupled to said inserter fastener;

wherein said plate comprises an internal wall that defines a through-hole to permit said inserter fastener of said inserter to pass therethrough so that said inserter fastener can be fastened to said at least one coupler of said cage;

wherein said plate is not securely coupled or fixed to said cage so that said plate can move, migrate or float with respect to said cage after said plate and said cage are implanted;

wherein said inserter simultaneously receives said plate and cage so that while said plate and cage are simultaneously co-implanted, said plate and cage are coupled together by said inserter and after said plate and cage are implanted and said inserter is removed from said plate and cage, said cage and plate are independent, uncoupled and separate components;

wherein said internal wall of said late defines said through-hole which comprises a shape that is generally the same and complementary as a shape of said inserter fastener.

2. The spinal implant co-insertion system as recited inclaim 1 wherein said inserter fastener is at an end of said inserter.

3. The spinal implant co-insertion system as recited inclaim 1 wherein said plate comprises a receiving shoulder and said inserter comprises an inserter shoulder integral with said inserter fastener, said inserter shoulder engaging said receiving shoulder when said inserter fastener is coupled to said at least one coupler to facilitate maintaining said plate and said cage in a generally adjacent position during a surgical procedure.

4. The spinal implant co-insertion system as recited inclaim 1 wherein said plate comprises said internal wall that is unthreaded and defines said through-hole for receiving said inserter.

5. The spinal implant co-insertion system as recited inclaim 1 wherein said internal wall is threaded and said inserter fastener is threaded.

6. The spinal implant co-insertion system as recited inclaim 1 wherein the end of said inserter fastener is threaded and said internal wall is threaded and adapted to threadably receive said threaded end of said inserter so that said threaded end may be screwed into both said plate and said cage.

7. The spinal implant co-insertion system as recited inclaim 1 wherein said plate comprises a bone-penetrating prong to facilitate stabilizing said plate during or following insertion or when said inserter is removed from said plate and cage.

8. The spinal implant co-insertion system as recited inclaim 1 wherein at least one of said cage or plate has an aligner for operatively aligning said cage and said plate together.

9. The spinal implant co-insertion system as recited inclaim 8 wherein said aligner is integrally formed in said plate.

10. The spinal implant co-insertion system as recited inclaim 9 wherein said aligner comprises at least one projection that causes said plate and cage to become aligned when they are received on said inserter.

11. The spinal implant co-insertion system as recited inclaim 8 wherein said aligner comprises a plurality of projections that cause said plate and cage to become aligned when they are received on said inserter.

12. The spinal implant co-insertion system as recited inclaim 11 wherein said cage comprises a plurality of aligning apertures for receiving said plurality of projections in order to align said cage relative to said plate.

13. A spinal implant co-insertion system, comprising: a cage having at least one coupler adapted to be fastened to an inserter having an inserter end;

a plate having a body;

said body having an internal wall that defines a through-hole for receiving said inserter having an inserter end that is screwed into said cage so that said inserter can simultaneously receive said cage and said plate so that they can be simultaneously implanted during a surgical procedure;

wherein said inserter end comprises at least one of threads, a cam, a key, a spread or a clamp, said cage being adapted to be fastened or coupled to said inserter end;

wherein said through-hole permits said inserter end of said inserter to pass therethrough so that said inserter end can be fastened to said at least one coupler of said cage;

wherein said plate is not securely coupled or fixed to said cage so that said plate can move, migrate or float with respect to said cage after said plate and said cage are implanted;

wherein said inserter simultaneously receives said plate and cage so that while said plate and cage are simultaneously co-implanted, said plate and cage are coupled together by said inserter and after said plate and cage are implanted and said inserter is removed from said plate and cage, said cage and plate are independent, uncoupled and separate components;

wherein said internal wall of said plate defines said through-hole which comprises a shape that is generally the same and complementary as a shape of said inserter end.

14. The spinal implant co-insertion system as recited inclaim 13 wherein said internal wall is threaded.

15. The spinal implant co-insertion system as recited inclaim 13 wherein said internal wall is threaded and adapted to threadably receive a threaded end of said inserter so that said threaded end may be screwed into both said plate and said cage.

16. The spinal implant co-insertion system as recited inclaim 13 wherein said plate comprises a bone-penetrating prong to facilitate stabilizing said plate during or following insertion or when said inserter is removed from said plate and cage.

17. The spinal implant co-insertion system as recited inclaim 13 wherein said plate comprises an aligner for operatively aligning said cage and said plate together.

18. The spinal implant co-insertion system as recited inclaim 17 wherein said aligner is integrally formed in said plate.

19. The spinal implant co-insertion system as recited inclaim 18 wherein said aligner comprises at least one projection that causes said plate and cage to become aligned when they are received on said inserter.

20. The spinal implant co-insertion system as recited inclaim 17 wherein said aligner comprises a plurality of projections that cause said plate and cage to become aligned when they are received on said inserter.

21. The spinal implant co-insertion system as recited inclaim 20 wherein said plurality of projections cooperate to define a receiving area for receiving and aligning said cage relative to said plate.

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